The Microbiology Laboratory will be the qualitatively leading independent microbiology laboratory in the Nordic countries for microbiological analyses for the medical device and pharmaceutical industry within the field of production hygiene, from raw material to finished product.
We carry out analyses for sterility, the presence of microorganisms and bacterial endotoxins on medical devices and in medications. The analyses are carried out in compliance with the relevant pharmacopoeia (Ph.Eur, USP) and standards.
Environmental control, clean room
Clean room validation as well as sampling, particles, air and surface control throughout Sweden, either by personnel from the laboratory or by personnel from our partner company, Renrumsteknik Nordic AB.
We carry out analyses of samples from 'sick buildings'.
Consultation and advisory services
We assist you in designing microbiological monitoring programmes and evaluate control programmes in the field of production hygiene.
Microbiological control and development projects
In addition to the accredited methods, we also offer customized testing and examinations in the field of microbiology according to customer request.
We carry out training programmes in production hygiene with respect to working in clean rooms, sampling, analysis and other areas, according to customer request.
A large measure of security
The laboratory is accredited in accordance with EN ISO/IEC 17025 in the field of production hygiene with respect to microbiology and is under the supervision of SWEDAC. Our quality system incorporates traceability in our analyses. We can guarantee good quality and therefore greater security for our customers.
The Microbiology Laboratory is also accredited in the field of environmental sampling and analysis, guaranteeing that sampling and analyses are carried out in accordance with internationally recognized standards.
More about accreditation
Accreditation is a formal recognition of proficiency in accordance with European and international standards. To maintain its accreditation, SWEDAC continuously evaluates the proficiency of the Microbiology Laboratory to conduct the testing, analyses and controls for which it is accredited.
SWEDAC, the Swedish Board for Accreditation and Conformity Assessment, is a public authority which in Sweden:
- is responsible for accreditation of laboratories, certification bodies, control and inspection bodies.
- evaluates and supervises notified bodies.
» More information about SWEDAC
The laboratory is also certified as a Quality Control Laboratory (QC Laboratory) for microbiological sterility and non-sterility testing for the release of medical products and is under the supervision of the Swedish Medical Products Agency with respect to fulfilment of GMP requirements in accordance with Directive 2003/94/EC.
» More information about the Swedish Medical Products Agency
We have no available jobs at this time.